High Level cGMP Compliance

What most manufacturers recognized as an insurmountable obstacle to cGMP compliance, Healthy Solutions saw as an opportunity. Manufacturing is a system, cGMP compliant manufacturing is an exponentially more complex system and design, development and operation of complex systems are what the owners of Healthy Solutions excel at. High level cGMP compliance & True Finished Goods Quality requires exhaustive raw material analysis, extraordinary process controls and unparalleled access / transparency to the massive amounts of data collected at each step of the cGMP Manufacturing Process.

Exclusive access to our proprietary cGMP managment system

Healthy Solutions™, LLC offers a one of kind computer-driven Quality Control and production system designed to eliminate the human error variable during the manufacturing process. Many companies opt for “off-the-shelf” quality control systems that cannot deliver the level of technical sophistication necessary to deliver the best possible product to the consumer. We invest heavily in manufacturing technology and the professionals responsible for managing that technology. Our in-house staff of expert programmers are constantly updating and creating new product manufacturing programs and processes to assure that you receive the highest quality products on time, every time.

“Well done is better than well said.”Benjamin Franklin

10+ YEARS AHEAD OF THE CURVE

Preoccupied by the costs, time & energy necessary to bring their facility into compliance, manufacturers failed to consider the affect that cGMP’s would have on their clients. Healthy Solutions however, did the exact opposite. We knew that our ability to provide automated solutions could be a huge competitive advantage. We knew that the True Value of a Manufacturer 2010 or 2015 would be radically different from that of 2003. However, we didn’t know exactly how. AN EXHAUSTIVE REVIEW OF THE CGMP’S, FDA GUIDANCE DOCS, INTERVIEWS, RESPONSES TO INDUSTRY INQUIRIES, ETC…LED US TO THE FOLLOWING CONCLUSIONS:

Connector.Connector.

A Manufacturers True Value will soon be defined by their ability to supply Brand Owners and Regulatory Agencies with the quality and quantity of data necessary to satisfy the requirements of Title 21 CFR part 111.

Connector.Connector.

Creation and Implementation of Customized Systems will be the Key to Maintaining High Level cGMP Compliance and Providing Customers with the Aforementioned True Value.

10+ YEARS OF CUSTOM CODE

Healthy Solutions system continues to evolve. It’s a customer driven process wherein all of our clients are encouraged to ask for data or request system improvements / modifications. The Healthy Solutions team of IT professionals will review each requests, determine its feasibility, scalability and priority. If the request is something which may benefit the majority of our client base it will be prioritized for production. If it’s a customer specific request, you’ll receive an estimate for the cost of development as well as a timeline to implementation.

“We fail to see how any manufacturer could achieve high level cGMP compliance without a system of this sort.”Healthy Solutions Ownership

REVOLUTIONARY CGMP MANAGEMENT & TRANSPARENCY

Healthy Solutions offers a one of kind computer-driven Quality Control and production system designed to eliminate the human error variable during the manufacturing process. Many companies opt for “off-the-shelf” quality control systems that cannot deliver the level of technical sophistication necessary to deliver the best possible product to the consumer. We invest heavily in manufacturing technology and the professionals responsible for managing that technology. Our in-house staff of expert programmers are constantly updating and creating new product manufacturing programs and processes to assure that you receive the highest quality products on time.

More Valuable Than Ever

FDA’s inspection and enforcements of Brand Owners continues leave Brand Owners shocked and dismayed at the inability or unwillingness of their “cGMP Manufacturer” to Provide Tangible Proof of Compliance Sufficient to Satisfy the FDA. Furthermore, the FDA has been reaffirming the need for Brand Owners to maintain the quality and quantity of documentation necessary to meet the Brand Owner requirements of title 21 CFR part 111. The day may or may not come when you are in need of the information a responsible manufacturer like Healthy Solutions, LLC is able to provide. If you are not already contracting with Healthy Solutions, LLC we would strongly encourage you to review the Brand Owner requirements of title 21 CFR part 111, contact your current or prospective manufacturer with a list of required items, documents, reports etc. and see how comfortable you would feel with their response given that the FDA in your office making those same requests.

Want The Right Vitamin Manufacturer? Ask the Right Questions!

Testing, Testing & more Testing!While many companies claim to provide you with quality, only a few actually have the equipment and expertise to do so.
Unfortunately, there are only a handful of manufacturers in the nation who perform the extensive raw material and finished goods testing that we do.Visit other facilities and Visit Healthy Solutions. Pay special attention to the lab, the difference will be clear.

Our Actions Align with our Words
Healthy Solutions has a strong reputation. The vast majority of our business comes from referrals. We’ve put our money where our mouth is in that while many make bold statements about their “quality process” few have made the $500,000 – $1,000,000 investment in laboratory equipment and personnel.

Healthy Solutions finds it hard to believe that a manufacturer can fully satisfy the cGMP requirements without a fully stocked analytical lab and multiple expert analytical chemists.

NO! Skip-lot testing is a major liability to you as a business owner and us as a contract manufacturer.

Skip lot testing is a schedule of testing wherein you only test the first few lots of raw material received from a supplier. Then, you “skip” testing the next few lots. Healthy Solutions DOES NOT perform skip lot testing.

Healthy Solutions performs a myriad of finished goods testing which typically includes all of the following:

High/Low quantitative assay on each finished good in order to validate the homogeneity of the blended and previously assayed ingredients (for example: if the formula contains 100mcg of Vitamin B12 and 1000mg of calcium we will assay each of those ingredients in the finished goods to validate appropriate mixing of the small weight and large weight ingredients within the batch).

SYSTEMS BUILT FOR SANITY

Our entire business model, systems and procedures are designed to ensure that every product we make, every action we take is monitored by our proprietary cGMP Process Management Software. There is no other system of this kind. For more than a decade, we’ve been working to ensure that when a challenge is identified, a process (program) is implemented to ensure that challenge never happens again. We can say with confidence that while statistically speaking we’ll never be perfect, so long as we work within the confines of the system there is little which can go wrong. No other manufacturer can offer you the same peace of mind. Computer controlled quarantine and material release. Computerized weigh out to prevent a small miscalculation from becoming a huge liability. Barcode controlled retention sample process. Automated recall procedures. And much, much more!

YOUR COMPETITIVE ADVANTAGE

Healthy Solutions™, LLC offers a one of kind computer-driven Quality Control and production system designed to eliminate the human error variable during the manufacturing process. Many companies opt for “off-the-shelf” quality control systems that cannot deliver the level of technical sophistication necessary to deliver the best possible product to the consumer. We invest heavily in manufacturing technology and the professionals responsible for managing that technology. Our in-house staff of expert programmers are constantly updating and creating new product manufacturing programs and processes to assure that you receive the highest quality products on time, every time. Complete material traceability from the receiving dock to the bottle via barcode scanning.

AUTOMATED COMMUNICATIONS

PO Confirmation

Customer Supplied Materials Needed

Customer Supplied Material Received

Shipping Confirmation w/ Tracking

Post Production Accounting

Ultra-Fast Access to Reports, Test Results

Healthy Solutions

Yes

Yes

Yes

Yes

Yes

Yes

“cGMP” Certified Competitors

No

No

No

No

No

No

Transparency and Reporting

Provides Raw Material Specifications

Provides Customers w/ Raw Material Test

Provides Customers w/ OOS Reports

Customer Supplied Inventory

Finished Goods Qualitative Analysis

Customer Specific Reports Available

Healthy Solutions

Yes

Yes

Yes

Yes

Yes

Yes

“cGMP” Certified Competitors

No

No

No

No

No

No

Automated Client Reports

Batch / MMR Raw Material Usage Reports

OOS, Deviation, Unexpected Events

C of A’s, Packing Slips, BOL, etc.

Pre-Production Acclerated Stability Reports

Finished Goods Qualitative Analysis

Customer Specific Reports Available

Healthy Solutions

Yes

Yes

Yes

Yes

Yes

Yes

“cGMP” Certified Competitors

No

No

No

No

No

No

QC LAB / ANALYTICAL

Inductively Coupled Plasma Mass

UPLC – Ultra High Pressure

Ultraviolet-Visible Spectrophotometry

NIR – Near Infrared Spectroscopy

Titrator – Automatic colorimetric

pH, Brix, TDS, Viscosity, Refractive

Healthy Solutions

Yes

Yes

Yes

Yes

Yes

Yes

“cGMP” Certified Competitors

No

No

No

No

No

No

All your gmp compliance information at your finger tips!

You can’t beat a quality conscious system designed to simplify all documentation required to remain cGMP compliant. Peace of mind and unequivocal quality are what makes Healthy Solutions the premier contract manufacturing partner. If you have any questions about our system or how we can easily plug into your existing system with our in-house team of IT experts, please click the button below and submit your information through the contact form. One of our IT specialist will follow up with you.